Safety of Sofosbuvir ,Daclatasvir in HCV Patients and RAVS in Resistent and Relapsed Cases

NCT03572140 | Unknown

• 1 other identifier: RAVS in HCV
• Study Type: observational
• Target: 297
• Locations: 0 countries
• Sites: N/A

Brief Summary

To identify side effects of Sofosbuvir/ Daclatasvir treatment regimen of chronic HCV GT-4 infection.

• To assess the occurrence and the prevalence of RAVs in patients with treatment failure and relapse after sofosbuvir and daclatasvir with assessment of their types .
• To examine the GT4 subtypes by phylogenetic analysis and baseline sequence variability among subtypes and their potential impact on treatment outcome and development of viral resistance in patients who received a regimen of Sofosbuvir/ Daclatasvir for treatment of chronic HCV GT-4.
• To assess the differences in patient demographics across GT4 subtypes.

Conditions

HCV

Keywords

HCV; Sofosbuvir; Safety; RAVs; Daclatasvir

Outcome Measures

Primary Outcomes (1)

• relevance of HC RAVs to the outcomes of therapy with Sofosbuvir in treatment of egyptian patients infected with HCV genotype 4

  that may be used in the future to predict the response to Sofosbuvir and this will save a huge cost for Egypt .

  baseline

Study Arms (2)

group A

RAVS IN resistent cases after daclatasvir plus sofosbuvir treatment

Diagnostic Test: RAVS In relapsed and resistent cases

group B

RAVS IN relapsed cases after daclatasvir plus sofosbuvir treatment

Diagnostic Test: RAVS In relapsed and resistent cases

Interventions

RAVS In relapsed and resistent cases DIAGNOSTIC_TEST

assessment of RAVS in relapsed and resistant cases after sofosbuvir plus daclatasvir regimen

group A; group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases will be recruited from the viral hepatitis clinic, department of tropical medicine, Alrajhi Liver hospital, Assiut University. The lab. work will be done by researchers from Medical Microbiology and Immunology department, Faculty of Medicine, Assiut University-University of Cincinnat, USA and Clinical pathology department, Assiut University.

You may qualify if:

• Anti HCV positive patients either chronic HCV or liver cirrhosis. • Detectable HCV RNA by quantitative polymerase chain reaction (PCR) prior to treatment

You may not qualify if:

• Co-infection with hepatitis B virus .
• Presence of malignancy before treatment.
• End-stage liver disease (Child score more than 9).
• Major co-morbid disease e.g heart failure

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Ben Ari Z. [Chronic hepatitis C infection--eradication of the virus]. Harefuah. 2014 Jul;153(7):392-3, 433. Hebrew.

  PMID: 25189028 BACKGROUND

• Conti F, Buonfiglioli F, Scuteri A, Crespi C, Bolondi L, Caraceni P, Foschi FG, Lenzi M, Mazzella G, Verucchi G, Andreone P, Brillanti S. Early occurrence and recurrence of hepatocellular carcinoma in HCV-related cirrhosis treated with direct-acting antivirals. J Hepatol. 2016 Oct;65(4):727-733. doi: 10.1016/j.jhep.2016.06.015. Epub 2016 Jun 24.

  PMID: 27349488 BACKGROUND

• Reig M, Marino Z, Perello C, Inarrairaegui M, Ribeiro A, Lens S, Diaz A, Vilana R, Darnell A, Varela M, Sangro B, Calleja JL, Forns X, Bruix J. Unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy. J Hepatol. 2016 Oct;65(4):719-726. doi: 10.1016/j.jhep.2016.04.008. Epub 2016 Apr 13.

  PMID: 27084592 BACKGROUND

• Kamal SM, Nasser IA. Hepatitis C genotype 4: What we know and what we don't yet know. Hepatology. 2008 Apr;47(4):1371-83. doi: 10.1002/hep.22127.

  PMID: 18240152 BACKGROUND

• Di Lello FA, Neukam K, Parra-Sanchez M, Plaza Z, Soriano V, Cifuentes C, Mira JA, Poveda E, Pineda JA. Hepatitis C virus genotype 4 in Southern and Central Spain does not originate from recent foreign migration waves. J Med Virol. 2013 Oct;85(10):1734-40. doi: 10.1002/jmv.23657. Epub 2013 Jul 16.

  PMID: 23861220 BACKGROUND

• Donaldson EF, Harrington PR, O'Rear JJ, Naeger LK. Clinical evidence and bioinformatics characterization of potential hepatitis C virus resistance pathways for sofosbuvir. Hepatology. 2015 Jan;61(1):56-65. doi: 10.1002/hep.27375. Epub 2014 Nov 20.

  PMID: 25123381 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

fresh blood sample at base line before treatment and another specimen after the end of treatment for resistent and relapsed cases

Study Officials

• Ahlam Farghaly, Professor

  Assiut University

  PRINCIPAL INVESTIGATOR

• haidi ramadan, Lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasha Ali, Assistant lecturer

CONTACT

01062821017; rasha.maree77@gmail.com

hellal hetta, Lecturer

CONTACT

01002386255; hellalhetta@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: June 28, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: June 29, 2018

Record last verified: 2018-06